To determine preventing effect of probiotics against radiation enteropathy, all the bacterial species level taxon derived from fecal samples of cancer patients will be identified by massive sequencing analysis and relative abundance of each taxon between two groups will be statistically compared.

In addition, overall microbial composition, kind of species and their abundance, in two groups will be compared with clustering method such as UPGMA and PCoA and the variation values between two groups will be calculated.

In the current study, we will determine the effectiveness of probiotics for the prevention of radiation induced complications with these two comparative analysis methods.

Secondary Outcome Measures:

Prevention of any grade of diarrhea and gastrointestinal symptoms [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Gastrointestinal symptoms will be scored according the Gastrointestinal symptom rating scale before and after RTx.

Diarrhea will be graded weekly according the Common Toxicity Criteria system.

Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.

Placebo Comparator: placebo

Placebo group. Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.

Placebo is composed of starch.Probiotics and placebo were similar in appearance, taste.

Dietary Supplement: Placebo

Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.

Detailed Description:

Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates changes in bacterial microbiome, the vascular permeability of the mucosal cells and in intestinal motility. Probiotics were known to improve gastrointestinal function. This is a randomized, double-blind, placebo-controlled study involving 26 patients designed to evaluate the effect of probiotics to change the intestinal microbiome in in patients undergoing concurrent pelvic/abdominal RT.

Eligibility

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital.

ECOG performance status (PS) of 0, 1, or 2.

signed written informed consent.

Patients who get pelvic/abdominal radiotherapy.

Exclusion Criteria:

People who use antibiotics that can affect intestinal microorganism growth within one month before the study.

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706393